Cleared Traditional

K031447 - CANON

K031447 is an FDA 510(k) clearance for CANON, manufactured by Canon, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K031447 · Canon, Inc. · Radiology device
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May 2003
Decision
14d
Days
Class 2
Risk

K031447 is an FDA 510(k) clearance for the CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Canon, Inc. (Lake Success, US). The FDA issued a Cleared decision on May 21, 2003 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Canon, Inc. devices

FDA 510(k) Submission Details - K031447

510(k) Number K031447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2003
Decision Date May 21, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 244
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K031447.
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
K042023 · Fujifilm Medical System U.S.A., Inc. · Aug 2004
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · Fujifilm Medical System U.S.A., Inc. · Nov 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K031633 · Canon USA, Inc. · Jun 2003
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K024147 · Varian Medical Systems, Inc. · Feb 2003
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K023750 · Canon USA, Inc. · Nov 2002
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K023586 · Canon USA, Inc. · Nov 2002